1. Field of the Invention
The present invention relates to a method and device for diagnosing or identifying patterns of human pathological conditions defined according to the principles of Traditional Chinese Medicine. More particularly, the invention pertains to an application of objective data obtained using modern analytic technologies as a diagnostic means to the practice of Traditional Chinese Medicine. Such an application would substantially reduce subjectiveness and inconsistency often associated with the pattern identification methods originally employed by the ancient healing art.
2. Description of the Related Art
Traditional Chinese Medicine (thereinafter xe2x80x9cTCMxe2x80x9d) has been in existence for several thousands of years and is based largely on accumulated human experience in fighting various diseases through the long history of Chinese civilization. Understandably, the development of TCM, including its diagnosis and treatment theories, did not benefit from modern science and technology and thus cannot be easily understood from the perspective of modern biology and medicine.
In TCM, human diseases are categorized by, first, the general patterns of imbalance of physiological conditions, i.e., pathological conditions and, then, by the specific organs affected by such imbalance. The most commonly used terms for general pathological patterns are: Heat, cold, excessive and lacking. These general conditions may affect one or more organs, such as heart, lung, spleen, liver, stomach, etc. It should be noted, however, that these references to organs do not have the same meanings in TCM as in modern medicine. For example, heart in TCM refers not only to the pumping object within one""s chest but, more importantly, also refers to one""s mind and spirit. Thus, anxiety or depression may be regarded as a heart disease in TCM. According to TCM, all diseases are caused by one or more of the general types of physiological imbalances and each type of imbalances has an identifiable pattern of clinical manifestations and requires a particular set of treatments for correction. Thus, to cure a disease, a doctor not only needs to treat the symptoms specific to the affected organ but also needs to treat the underlying general imbalance which, to some extent, is more important. Therefore, it is very important for a TCM doctor to correctly identify the underlying general disease patterns.
Traditionally, a TCM doctor relies on four types of examination to identify disease patterns and provide treatment accordingly: observation-inspection, listening-smelling, inquiry and palpation. Those types of examinations rely heavily on the doctor""s subjective judgment and different diagnostic results are often obtained from different doctors examining the same subject. Therefore, it is highly desirable to have some objective means to help TCM doctors in disease pattern identification. Although, efforts have been made to link xe2x80x9cyin-yangxe2x80x9d to cellular levels of cAMP-cGMP, no one to applicants"" knowledge has heretofore developed or suggested a practical use of objective biological data as a diagnostic means to be used in TCM. The present invention, by providing an association between a biochemical marker and a disease pattern of TCM, advances TCM into the modern era. It provides more objective and consistent identifications of disease patterns for better treatment results. It also provides a better understanding of TCM and makes it more acceptable to more people.
The methods of diagnosing and treating allergic asthma, for instance, have been very different according to TCM and western medicine. Although the incidence and severity of allergic asthma seem to be rising, western methods of treatment still stem from empirical and serendipitous findings rather than from a scientific approach (Barnes, P. J. A new approach to the treatment of asthma. N Engl J Med. 321:1517-27, 1989). At present, allergic asthma may be treated using different approaches. Drug treatment that aimed at controlling the symptoms resulting from the release of mediators by effector cells seems in short-term studies to be effective, with a low frequency of adverse effects. Long-term oral steroid therapy is associated with multiple debilitating effects, such as growth delay, osteoporosis, and adrenal suppression. As a result, steroid agents are often attempted in patients.
The alternative view in the treatment of asthma is TCM. One of the most comprehensive anti-asthma TCM clinical trial, a multi-center, double-blind and placebo-controlled study, was reported in Taiwan (Hsieh, K.H. Evaluation of efficacy of traditional Chinese medicines in the treatment of childhood bronchial asthma: clinical trial, immunological tests and animal study. Pediatr Allergy Immunol. 7:130-140, 1996). The results showed that the TCM treatments were beneficial to the patients, while many other clinical indicators did not show statistically significant differences between treatment and placebo. One of the reasons is probably the essence of TCM diagnosis was not clearly included in the trial.
TCM diagnosis depends on the doctor""s sense of the patient""s organs to acquire clinical information, then to analyze, generalize and infer the patient""s condition without resorting to any apparatus. The reason why a doctor can diagnose internal pathological changes merely by observation and analysis of external signs when he is unable to inspect directly the pathological changes in the interior is that the human body is an organic whole, with its parts intimately and inseparably connected with each other by the channels and collateral. So pathological changes inside of the human body are inevitably shown outwardly as abnormalities in complexion, spirit, picture of the tongue and the pulse (Hsu H.Y., and W.G. Peacher. General Diagnosis in Chinese Herbal Medicine. In: Chinese Herb Medicine and Therapy. New Canaan: Oriental Healing arts Institute of the United States, 1982, pp. 19-26). Therefore, only by accurate differentiation of syndromes can we work out effective treatments according to the condition of the disease. The treatment of asthma in TCM is based on the differentiation of xe2x80x9cheatxe2x80x9d zheng according to the patient""s outward manifestations. However, there is little published work to provide objective evidences for the nature of zheng.
Heat syndrome indicates functional hyperreactivity of the body, arising from affection of pathogenic heat, or fire transformation from disorder of the emotions, and hyperreactivity of yang due to deficiency of yin. Heat syndrome is typically shown as dryness of the mouth, slight thirst, red tip and borders of the tongue, floating and rapid pulse, preference for drinking, scanty dark urine, constipation (Kuwaki, T. Introduction to Chinese Herbal Therapy. In: Chinese Herbal Therapy. Long Beach: Oriental Healing Arts Institute. 1990, pp. 21-38). In our clinic, we found asthmatic patients presented their symptoms in varying pattern.
Oriental medical doctors will treat these patients in different ways based on the results of differentiation of syndromes. Patients who exhibit yellowish mucoid sputum, thirst, onset closely associated with heat, reddened tongue with yellow greasy fur, slippery and rapid pulse will be treated by removing heat-phlegm and facilitating the flow of the lung-qi to relieve asthma. In our studies, patients with blood-shot eyes, aversion to heat, thirst with desire for drinking, constipation, dark scanty urine and red tongue with yellow fur were classified into xe2x80x9cheatxe2x80x9d zheng. On the other hand, patients without these presentations were classified into xe2x80x9cnon-heatxe2x80x9d zheng.
The present invention found that asthmatic patients with typical heat xe2x80x9czhengxe2x80x9d presentation always had higher ECP serum level. Therefore we believe that ECP should be one of the pathogenic pathway of heat zheng presentation.
Eosinophils play an important role in the pathogenesis of bronchial asthma. Eosinophil cationic protein (ECP) as a cytotoxic performed mediator stored in eosinophil granules and released under various in vitro and vivo conditions (Koller, D.Y, Y. Herouy, M. Gotz, E. Hagel , R. Urbanek, and I. Eichler. Clinical value of monitoring eosinophil activity in asthma. Arch Dis Child. 73:413-417, 1995; Remes, S., M. Korppi, K. Remes, K. Savolainen, I. Mononen, and J. Pekkanen. Serum eosinophil cationic protein and eosinophil protein X in childhood asthma. Pediatr Pulmonol. 25:167-174, 1998). A correlation has been documented between the activity of the eosinophils in the lungs and the level of ECP in serum. In addition, ECP is a sensitive marker for monitoring of the disease activity in asthma and offer a useful tool for estimating treatment efficacy (Niimi, A., R. Amitani, K. Suzuki, E. Tanaka, T. Murayama, and F. Kuze. Serum eosinophil cationic protein as a marker of eosinophilic inflammation in asthma. Clin Exp Allergy 28:233-240, 1998). Studies have indicated a relation between level of serum ECP and activity and severity in asthma. Therefore measurement of ECP indicates the activity of activated eosinophils. Until the present invention, however, there has been no correlation of the patient""s ECP serum level to the patient""s classification as being within xe2x80x9cheatxe2x80x9d zheng or xe2x80x9cnon-heatxe2x80x9d zheng.
In accordance with the present invention, a disease pattern categorized according to TCM can be linked to one or more biochemical markers. By measuring those markers, a TCM doctor can better identify TCM disease patterns, more objectively and consistently, especially in patients suffering from allergic disorders, such as rhinitis, asthma, and eczema. Further, according to the present invention, analytical kits for the measurement can be manufactured, making the identification more economical and convenient.
As one of the embodiments of the present invention, the serum level of ECP (serum eosinophil cationic protein) was used to correctly identify patients with the Heat Pattern of allergic rhinitis, which is traditionally identified by so-called xe2x80x9cheat syndromexe2x80x9d or xe2x80x9cheat zhengxe2x80x9d: dryness of the mouth, slight thirst, red tip and rim of the tongue, floating and rapid pulse, scanty dark urine and constipation. The serum ECP level can be objectively and quantitatively measured by using one of various biochemical assays, such as radioimmunoassay or fluorescence enzyme-linked immunosorbent assay. Such a measurement is in contrast to the traditional pattern identification method, as aforementioned, which is more subjective and qualitative and must be determined by experienced clinical TCM doctors. In addition, ECP assay kits can be manufactured in large scale to further reduced the costs and permit the assay to be performed by ordinary lab technicians.
Therefore, one of the objectives of the present invention is to provide a diagnostic method for identifying TCM disease patterns more objectively and consistently. This objective is achieved by providing a direct link between a disease pattern and one or more biochemical markers which can be objectively measured.
Another objective of the present invention is to provide a more convenient and more economic way for clinical disease pattern identification. This objective is achieved by providing standardized assay kits manufactured in large scale.
Other objects and features of the present invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the invention, for which reference should be made to the claims.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of the disclosure. For a better understanding of the invention, its operating advantages, and specific objects attained by its use, reference should be had to the drawing and descriptive matter in which there are illustrated and described preferred embodiments of the invention.